This invention relates to a surgical technique and an associated instrument or device. More particularly, this invention relates in part to a method of using tools vibrating at ultrasonic frequencies for treating specific diseases of the human body.
Human breast disease in both males and females can have catastrophic consequence not only for the patients but to their families, for many years even after the untimely death of the loved one. Because of the activism of many groups, the funding levels of research into the causes and treatments of breast disease is one of the highest today. Although great strides have been made in the diagnosis and treatment of breast cancer in humans and the survival rates have been drastically improved over those of even twenty years ago, much work needs to be done to improve both the diagnostic techniques and treatment of these maladies.
One of the issues is the characterization of lesions within the body after the initial discovery by palpation, mammography or other radiological diagnosis tools. A mass that shows up by any of these techniques may be a benign fatty deposit, a hard fibroid or a cancerous lesion. The long-term prognosis for the patient is vastly different for each of these, of course. A biopsy will generally be taken of the lesion with a standard cannula and then sent to a pathologist for examination. Where cancer cells have been found in the biopsy sample, a lumpectomy or mastectomy will be performed. As an alternative, radiation treatments and/or chemotherapy may be used in some cases.
Where the biopsy is negative for cancer cells or is inconclusive, a period of watchful waiting is generally chosen. Here the patient is told to wait and to schedule periodic visits for reexamination, to see if the lesion changes size or shape. If it does, another biopsy will be performed to determine if cancer cells are present or not. This repeated examination and the anxiety associated with the possibilities of prognosis is akin to living under the Sword of Damocles for many people. They would prefer that the lump or mass be removed immediately and be done with it. However, this is not always possible without major surgery to get to the site and remove the mass via open field procedures. The scars and the resultant effect of changing the shape of the breast could lead to esthetic concerns in women especially, which will lead to further cosmetic surgery to correct these abnormalities. Insurance companies generally will balk at having to pay the high costs associated with major surgery for a diagnosis which is not immediately threatening to the life or health of the patient. Even when payment is available, the time and potential consequences of the treatment may make the operation unacceptable to the patient, who may delay the procedure until such time as it is absolutely necessary, notwithstanding the psychological consequences.
If a minimally invasive technique existed which would allow the surgeon to go in and remove the mass totally without resorting to open field procedures, more people would opt for quick excision of the mass at its discovery. This would improve quality of life of the patient and result in fewer precancerous masses that become malignant and ruin lives in the process. Attributes of the device and method would be a minimal incision size, full visibility of the target lesion, and the ability to remove any or all of the suspect tissue at the surgeon's discretion, as well as simplicity of operation and an inexpensive cost that would encourage widespread use in clinics and outlying hospitals.
It is therefore desired to create hardware and associated methods that will allow the dissection and aspiration of a tissue volume from the body consistently, with minimal trauma and esthetic impact.